Z-2405-2024 Class II Ongoing
FDA device recall Z-2405-2024 was initiated by Stryker Sustainability Solutions on May 31, 2024 and is designated Class II. Reason for recall: Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. The recall status is ongoing. Affected quantity: 90 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 24, 2024
- Initiation Date
- May 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 units
Product Description
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Reason for Recall
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Distribution Pattern
US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
Code Information
Lot: 0000564862/ UDI: 00885825015411
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2405-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026